322571 VU Technological and Biopharmaceutical Aspects of Biologics - M7/M14 (2022W)
Continuous assessment of course work
Labels
Registration/Deregistration
Note: The time of your registration within the registration period has no effect on the allocation of places (no first come, first served).
- Registration is open from Mo 03.10.2022 12:00 to Tu 25.10.2022 12:00
- Deregistration possible until Tu 25.10.2022 12:00
Details
Language: English
Lecturers
Classes
Montag 07.11.2022 - 09:45 - 11:15 Uhr 2E411
Mittwoch 09.11.2022 - 09:45 - 11:15 Uhr 2F161
Donnerstag 10.11.2022 - 09:45 - 11:15 Uhr 2E411
Montag 14.11.2022 - 09:45 - 11:15 Uhr 2E411
Mittwoch 16.11.2022 - 09:45 - 11:15 Uhr 2F161
Montag 21.11.2022 - 09:45 - 11:15 Uhr 2E411
Mittwoch 23.11.2022 - 09:45 - 11:15 Uhr 2F161
Information
Aims, contents and method of the course
Assessment and permitted materials
The individual completion of two Microsoft Excel spreadsheet-based data calculation, presentation and interpretation exercises, form the assessment for this course.
The subjects of these exercises are:
Shelf life prediction calculation exercise (25 marks available)
Pharmacokinetics calculation exercise (25 marks available)
The subjects of these exercises are:
Shelf life prediction calculation exercise (25 marks available)
Pharmacokinetics calculation exercise (25 marks available)
Minimum requirements and assessment criteria
An aggregate total of 50 marks (the sum of the results of the two assessment exercises) will provide the final grade for the course according to the following grading scheme:1 (excellent) 50 – 44 points
2 (good) 43 – 38 points
3 (satisfactory) 37 – 32 points
4 (sufficient) 31 - 25 points
5 (insufficient) 24 – 0 points
2 (good) 43 – 38 points
3 (satisfactory) 37 – 32 points
4 (sufficient) 31 - 25 points
5 (insufficient) 24 – 0 points
Examination topics
Reading list
Wang & Ohtake, Science and art of protein formulation development. International Journal of Pharmaceutics (2019) 568:118505
https://doi.org/10.1016/j.ijpharm.2019.118505Anselmo, Gokarn & Mitragotri, Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery (2019) 18:19–40
https://doi.org/10.1038/nrd.2018.183Rugo et al., Demystifying biosimilars: development, regulation and clinical use. Future Oncology (2019) 15
https://doi.org/10.2217/fon-2018-0680
https://doi.org/10.1016/j.ijpharm.2019.118505Anselmo, Gokarn & Mitragotri, Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery (2019) 18:19–40
https://doi.org/10.1038/nrd.2018.183Rugo et al., Demystifying biosimilars: development, regulation and clinical use. Future Oncology (2019) 15
https://doi.org/10.2217/fon-2018-0680
Association in the course directory
MA8, MA23
Last modified: Th 27.10.2022 10:30
This course will be taught and assessed in EnglishAIMS
At the end of this course, participants should:
- Understand the formulation principles for biotechnology products.
- Understand the challenges of protein formulations and how these are addressed through preformulation.
- Recognise the roles of various excipients in protein formulation.
- Understand the principles of shelf-life prediction and be able to calculate shelf-life using appropriate experimental data.
- Understand the role of formulation in improving the release characteristics, bioavailability and efficacy of biologics, via parenteral and non-parenteral routes.
- Understand the basic concepts of pharmacokinetics and how these apply to macromolecule delivery.
- Understand basic pharmacokinetic models, and apply them to the calculation of pharmacokinetic parameters from appropriate experimental data.
- Be able to compare and draw basic conclusions from self-analysed experimental pharmacokinetic data.
- Be able to use Microsoft Excel to analyse experimental biopharmaceutical data and present graphs comparing different experimental conditions.CONTENTS
The course will cover both preformulation and formulation aspects of biologics, including both protein and nucleic acid-based therapeutics. Adaptations in formulation for different routes of administration will be discussed, together with how release kinetics may be improved. Biopharmaceutical aspects of macromolecular delivery will be discussed in relation to improving pharmacokinetic profiles through formulation changes. Emphasis is placed on understanding and comparing experimental data.METHODS
This course will be taught using a mixture of lectures and tutorials (a total of 7 sessions). Practice exercises in data handling and presentation using Microsoft Excel provided, to help with each assessment.